Intertek Testing Services NA Ltd. Company Services
Management system certification
At Intertek, we can provide you with the industry-specific expertise you need to gain market access and maximize revenue potential. We are your single source for certification and testing services, regardless of your target market:
ISO 13485:2003 provides QMS requirements for medical device manufacturers. Many regulatory authorities around the world have adopted (or will adopt) this standard.
ISO 14971:2007 provides requirements for risk management systems. Many global standards and regulatory requirements now include references to this standard and require you to have a documented risk management system in place.
For market entry in the EU, our Notified Bodies can provide you the assessment needed under the Medical Device Directive (MDD) for CE marking.
In the US, we are accredited by the FDA to conduct inspections on their behalf under the Accredited Persons (AP) Inspection Program. We are also accredited by the FDA to conduct initial reviews of eligible Premarket Notifications required by section 510(k) of the Federal Food Drug and Cosmetic Act.
For manufacturers applying for device licenses in Canada, Intertek is recognized by Health Canada to provide the ISO 13485 certification required under the Canadian Medical Device Conformity Assessment System (CMDCAS) program.
Through our partner certification body, Spindler Associates, we can provide quality system (GMP) assessments required to satisfy the Pharmaceutical Affairs Law (PAL) in Japan.
Intertek Testing Services NA Ltd. Company Business Activity
Other Scientific and Technical Consulting Services